The US Food and Drug Administration is paying more attention to process-related impurities now that process-related potential carcinogens have been found in certain blood pressure and heart failure medications, says Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research.
US FDA Scrutinizes Process Risks After Nitrosamines Found In ARBs
There is a new focus in reviews and inspections where nitrosamines or other dangerous process-related impurities might form.
